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Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Adapalene/Benzoyl Peroxide

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne vulgaris, Adapalene, Benzoyl Peroxide

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A clinical diagnosis of acne vulgaris with facial involvement.
A minimum of 20 but not more than 50 inflammatory lesions
A minimum of 30 but not more than 100 noninflammatory lesions
A score of 3 (Moderate) on the Investigator's Global Assessment Scale

Sites / Locations

Miller MD

Outcomes

Primary Outcome Measures

Success rate on the Investigator's Global Assessment

Change in inflammatory lesion counts

Change in noninflammatory lesion counts

Secondary Outcome Measures

Percent change in lesion counts (inflammatory, noninflammatory, total)

Change in Investigator's Global Assessment (IGA)

Subject's assessment of acne

Full Information

NCT ID

NCT00422240

First Posted

January 11, 2007

Last Updated

February 16, 2021

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT00422240

Brief Title

Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

Official Title

A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris

Study Type

Interventional

2. Study Status

Record Verification Date

September 2007

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Galderma R&D

4. Oversight

5. Study Description

Brief Summary

This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study. The primary objective is to demonstrate the superiority in efficacy and assess safety of adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

Keywords

Acne vulgaris, Adapalene, Benzoyl Peroxide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

1656 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Adapalene/Benzoyl Peroxide

Primary Outcome Measure Information:

Title

Success rate on the Investigator's Global Assessment

Title

Change in inflammatory lesion counts

Title

Change in noninflammatory lesion counts

Secondary Outcome Measure Information:

Title

Percent change in lesion counts (inflammatory, noninflammatory, total)

Title

Change in Investigator's Global Assessment (IGA)

Title

Subject's assessment of acne

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A clinical diagnosis of acne vulgaris with facial involvement. A minimum of 20 but not more than 50 inflammatory lesions A minimum of 30 but not more than 100 noninflammatory lesions A score of 3 (Moderate) on the Investigator's Global Assessment Scale

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Graeber, MD

Organizational Affiliation

Galderma R&D

Official's Role

Study Director

Facility Information:

Facility Name

Miller MD

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12963896

Citation

Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. doi: 10.1067/s0190-9622(03)01154-x.

Results Reference

background

PubMed Identifier

19746769

Citation

Gold LS, Tan J, Cruz-Santana A, Papp K, Poulin Y, Schlessinger J, Gidner J, Liu Y, Graeber M; Adapalene-BPO Study Group. A North American study of adapalene-benzoyl peroxide combination gel in the treatment of acne. Cutis. 2009 Aug;84(2):110-6.

Results Reference

derived

Links:

URL

http://www.galderma.com/

Description

Related Info

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Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

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